(323 days)
Not Found
No
The summary describes a laser system for soft tissue ablation and resurfacing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The device description focuses on the laser technology and handpieces.
Yes
The device is indicated for use in various medical and dental procedures involving the ablation, resurfacing, coagulation, vaporization, excision, and incision of soft tissue, all of which are considered therapeutic actions.
No
The device is described as a laser system used for therapeutic procedures such as ablation, resurfacing, coagulation, incision, and excision of soft tissue, rather than for diagnosing conditions.
No
The device description explicitly states that the systems utilize a "CO2 RF module to generate a laser beam" and "different handpiece for different indications for use," indicating the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The intended use of the eCO2 Plus, SP III, DENTA III, and DENTA III+ Laser Systems is for surgical procedures requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue. This involves direct interaction with the patient's body for therapeutic purposes.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any specimens from the human body. The device directly treats tissue.
Therefore, the function and intended use of these laser systems fall under the category of surgical or therapeutic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The eCO2 Plus Laser System with fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The eCO2 Plus Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is also indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing .
- . Treatment of wrinkles, rhytids and furrows
- . Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction. removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgerv
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Indications for Use:
The DENTA III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
Indications for Use:
The DENTA III+ Laser System using fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Indications for Use:
The DENTA III+ Laser System using non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional bionsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
Indications for Use:
The SP III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Dermatology & Plastic Surgerv
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing .
- . Treatment of wrinkles, rhytids and furrows
- Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the . reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgerv
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Product codes
ONG, GEX
Device Description
The eCO2 Plus, SP III, DENTA III and DENTA III+ Laser Systems utilize a CO2 RF module to generate a laser beam with a wavelength of 10.6 um and use different handpiece for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The Laser Systems are supplied with different handpieces depending upon the device configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, periodontal pocket, root surface, oral cavity, cervix, vulva, vagina, brain (basal turnor-meningioma, posterior fossa tumors), nerves (peripheral neurectomy), skin, eye (blepharoplasty), anus (hemorrhoids), ear/nose/throat (choanal atresia, larynx, nasal obstruction, UPP, rhinophyma, papillomatosis polyps), knee (arthroscopy).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery, soft tissue dental indications.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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100610 pg 1 6
510(k) Summary for the Lutronic Corporation eCO2 Plus, DENTA III, SP III Laser Systems
JAN 2 0 2011
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92, and 21 CFR 878.4810.
1. General Information
Submitter:
Lutronic Corporation #403-2,3,4, Ilsan Technotown 1141-1 Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea
Contact Person:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-824-2541
Summary Preparation Date:
- Names
Device Name:
Classification Name:
eCO2 Plus Laser System DENTA III Laser System DENTA III+ Laser System SP III Laser System
January 19, 2011
Powered Laser Surgical Instrument With Microbeam\Fractional Output Laser Instrument, Surgical, Powered Product Code: ONG GEX Panel: General & Plastic Surgery Regulation number: 21 CFR 878.4810
3. Predicate Devices
The eCO2 Plus, DENTA III, DENTA III+ and SP III Laser Systems are substantially equivalent to a combination of the Lutronic Corporation eCO2 Laser System (K091115) and the Lutronic Corporation Spectra SP II and Spectra DENTA II Laser Systems (K091320).
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2 of 5
4. Device Description
The eCO2 Plus, SP III, DENTA III and DENTA III+ Laser Systems utilize a CO2 RF module to generate a laser beam with a wavelength of 10.6 um and use different handpiece for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The Laser Systems are supplied with different handpieces depending upon the device configuration.
5. Indications for Use
The eCO2 Plus Laser System with fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The eCO2 Plus Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is also indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing .
- . Treatment of wrinkles, rhytids and furrows
- Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the . reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
2
100610 pg 3 of 5
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal turnor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
The DENTA III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia: partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The DENTA III+ Laser System using fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The DENTA III+ Laser System using non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and turnors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum
3
(100610
preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The SP III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- . Laser skin resurfacing
- . Treatment of wrinkles, rhytids and furrows
- . Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
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100610 Pg 5 of 5
1000
6. Performance Data None presented.
.
・ ・ . ・ :
5
Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a semi-circle around the left side of the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Lutronic Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
JAN 2 0 2011
Re: K100610
Trade/Device Name: eCO2 Plus Laser System Fractionated and Non-Fractionated Handpieces; DENTA III Laser System - Non-Fractionated Handpieces; DENTA III+ Laser System Fractionated and Non-Fractionated Handpieces; SP III Laser System - Non-Fractionated Handpieces Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG, GEX Dated -- January-03-201-1-Received: January 04, 2011
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
6
Page 2 -- Ms. Maureen O'Connell
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ai
Dr. B. 2 h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known): K100610
Device Name: eCO2 Plus Laser System-Fractionated Handpieces
Indications for Use:
The eCO2 Plus Laser System with fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Neil R P Ogden for mxm
Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number |
|-----------------------------------|----------------------------------------|
| (Division Sign-Off) | Page 4 of 8 |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |
CONFIDENTIAL
510(k) Number K100610
11
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: DENTA III+ Laser System-Fractionated Handpieces
Indications for Use:
The DENTA III+ Laser System using fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for 15 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x Page 5 of 8
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
CONFIDENTIAL
510(k) Number K100610
12
Klooglo
510(k) Number (if known):
Device Name: DENTA III+ Laser System-Non-Fractionated Handpiece
Indications for Use:
The DENTA III+ Laser System using non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional bionsy, incision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neiller for more
Page 6 of 6
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
CONFIDENTIAL
| 510(k) Number_________________________________________________________________________________________________________________________________________________________________ | ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | Klooblo | |
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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boo610
510(k) Number (if known):
Device Name: SP III Laser System-Non-Fractionated Handpieces
Indications for Use:
The SP III Laser System using the non-fractionated handpieces (F100, F50, and Zoom) is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
Dermatology & Plastic Surgerv
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing .
- . Treatment of wrinkles, rhytids and furrows
- Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the . reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery
Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dahlen for mkn
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
CONFIDENTIAL
510(k) Number K100610
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Kbo Glo
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares.
Gynecology
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgerv
Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use -(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 8 of 8
Neil R. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100610